In the Specification of my copending Application Ser. No. 338,257 (U.S. Pat. No. 4,009,265), there is described and claimed a method for the treatment of obesity in man, which comprises the steps of giving the overweight patient a daily diet consisting essentially of,
(a) at least the minimum daily requirement of all the minerals required by man, including at least 800 mg calcium, 800 mg phosphorus, 140 .mu.g iodine, 10 mg iron and 350 mg magnesium; PA1 (b) proteinaceous material selected from at least one member of the class consisting of: PA1 (c) digestible carbohydrate; PA1 (d) at least the minimum daily requirement of all the vitamins required by man; and PA1 (e) sufficient fat, oil or other source of essential fatty acid to supply the patient's minimum fatty acid requirements; PA1 (a) all the minerals required by man; PA1 (b) proteinaceous material selected from the class consisting of: PA1 (c) digestible carbohydrate;
(i) a mixture of monomeric L-aminoacids, and PA2 (ii) natural proteins, and PA2 (iii) natural proteins reinforced with at least one monomeric L-aminoacid; PA2 (i) a mixture of monomeric L-aminoacids, and PA2 (ii) natural proteins, and PA2 (iii) natural proteins reinforced with at least one monomeric L-aminoacid; and
said method being characterized in that the amount of proteinaceous material given daily is at least 15 g and contains at least the minimum daily requirements for man of all the essential L-aminoacids required by man, and the amount of carbohydrate given daily is from 15 g to 75 g, and that the total caloric value of the daily diet is in the range of from 160 Kcals to 600 Kcals.
In that dietary method for the treatment of obesity, which for convenience I will sometimes hereinafter call "my diet", it is advantageous to give the overweight patient a complete diet formulation which contains at least all the components (a), (b) and (c), and preferably also components (d) and (e) set out above, in the appropriate proportions, so that he can use the formulation (if necessary mixed with water) as his sole means of nutrition until the desired loss of body weight has been achieved.
Thus in the Specification of my aforesaid Application Ser. No. 338,257 there is also described and claimed a dietary formulation for the treatment of obesity in man, which comprises:
characterized in that the smallest amount of the dietary formulation containing at least the minimum daily requirements of each of the minerals required by man including at least 800 mg calcium, 800 mg phosphorus, 140 .mu.g iodine, 10 mg iron and 350 mg magnesium, also contains:
(A) at least 15 g of said proteinaceous material which must include at least the minimum daily requirements for man of all the essential L-aminoacids required by man; and
(B) from 15 g to 75 g of the digestible carbohydrate; and further characterized in that the total caloric value of said smallest amount of the dietary formulation is in the range of from 160 Kcals to 600 Kcals.
The dietary requirements of man and the minimum daily amounts of the various constituents of a healthy diet are of course discussed in detail in my aforesaid Application Ser. No. 338,257, the disclosure of which is incorporated herein by cross-reference. The methods and formulations there described and claimed have proved to be very effective in the treatment of obesity, and excellent results have been achieved. Unfortunately however the complete dietary formulations disclosed in my Application Ser. No. 338,257 are somewhat costly to make and to market, and tend to be rather uninteresting and often objectionable in flavour.
Attempts to overcome these drawbacks to the widespread acceptance of my diet have led me to the recognition that in general most people find milk palatable, and that even today milk still remains a relatively low-cost source of many of the essential ingredients of any diet. Milk was of course suggested as a possible source of natural protein and carbohydrate in my aforesaid Application Ser. No. 338,257 and can be used in accordance with the general direction given there for both the diet and the formulations.
Skimmed milk is preferred, since it is much lower in calorie content than whole milk, and yet contains all the other nutrients besides those present in the milk fat. For instance, it is a good source of protein and carbohydrate, sufficient to meet the requirements over a considerble range of the diet of my aforesaid Application Ser. No. 338,257. It also contains substantial amounts of calcium and phosphorus, though enough to meet requirements over only the upper part of the range within which the skimmed milk fulfills the requirements of the diet for protein and carbohydrate. Skimmed milk is however sadly deficient, to varying degrees, in other minerals required by man; and it is also inadequate or lacking in many of the vitamins and also in the essential fatty acid(s) required by man.
What therefore is needed, if skimmed milk-based diets in accordance with my aforesaid Application Ser. No. 338,257 are to be widely adopted, is a ready-formulated supplement which, when administered to the patient in conjunction with skimmed milk either in liquid or in powder form, will complement and make good the nutritional deficiencie (by which of course I mean the deficiencies in relation to the intended dietary regime) of the skimmed milk. Given some predetermined level of administration of skimmed milk to the patient, it is though complicated nevertheless quite possible to calculate the nutritional deficiencies of that amount of skimmed milk, and thus to work out how much more of additional nutrients must also be administered to the patient.
The problem which I have set out to solve is not however as simple as that, since for practical usefulness such a supplement must not only enable the clinician to vary the severity of the diet within permissible limits but also must allow for some margin of error in the measurement of the quantities of skimmed milk (and perhaps even of the supplement) which the patient takes at any one time. Moreover, while in carefully-supervised hospital treatment it may well be practical to administer various elements of the diet separately to the patient, if he is to adhere to the diet in the uncontrolled environment of his own home it is highly desirable that the variety of different elements of the diet which must be taken should be as few as possible, and that each of them should be as palatable as possible. Nor are these the only considerations-for precise control of the amount of supplement administered at any one time it is distinctly preferable to formulate it as tablets or the like, but it is well-known that most patients display some resistance to taking either too large a tablet or too many smaller tablets.
There is currently no commercially-available formulation which contains the minerals and vitamins, far less the other necessary chemicals including essential fatty acid(s), in a form suitable for use as a supplement to skimmed milk in my diet. There are indeed some dietary formulations which contain some of the necessary minerals in the right proportions, but being designed with other aims in view they contain substantial quantities of carbohydrate and other ingredients, which raise them way above the uppermost limits of my diet, namely 75g carbohydrate and/or 600 Kcalories per day. Leaving aside all such high-calorie diets and other foodstuffs, which are ruled out for that reason, there are of course vitamin tablets on the market which in some cases also include minerals. Such vitamins-plus-minerals tablets are however intended to be used as a supplement to normal food which contains ample amounts of many of the necessary minerals, such as sodium, potassium and magnesium, and consequently the alreadyavailable tablets do not contain sufficient of these minerals to supplement my low-calorie milk-based diet.